ANZCTR search results

The primary aim of the study is to test the usefulness of melatonin treatment in delayed sleep phase patients who present with delayed melatonin rhythms.

High sodium intake, as measured by urinary sodium excretion, is associated with increased bone loss (Divine, 1995). In Australia, the national target for salt intake was achieved by only 6% of men and 36% of women (Beard, 1997). A positive relationship exists between urinary sodium and urinary calcium excretion, with repeated studies showing that a high level of salt in the diet increases calcium excretion (Ilich, 2000). Other studies have recognised that people following a gluten-free diet have a lower bone mineral density, likely related to calcium malabsorption (Scott, 2000). It is not clear from the research how much sodium is ingested by those following a gluten free diet.

Aim We aim to show that giving intravenous iron polymaltose over 10 minutes to patients who are under general anaesthesia is convenient, safe and not associated with a significant incidence of low blood pressure or other adverse effects. Background - Anaemia and iron deficiency are very common in surgical patients. A recent audit at KEMH, the tertiary womens hospital in WA, showed that 18% of women were anaemic prior to their gynaecological surgery. In patients undergoing surgery anaemia has been linked with an increased risk of needing a blood transfusion, slower recovery from surgery and an increase in postoperative complications. Patients often suffer from decreased energy, fatigue and poor ability to concentrate, all of which will affect their quality of life. - Iron polymaltose is an intravenous iron medication commonly used to correct anaemia and iron deficiency. It has been used in Australia for over 40 years, has a very good safety record and about 4-500 women a year receive iron polymaltose at KEMH currently. It is usually administered as a slow infusion over 2 - 3 hours in a general ward setting. Common adverse effects can include headache, nausea, flushing, low blood pressure and muscle cramps all of which are not as relevant to patients whilst they are under general anaesthesia. Serious adverse events such as anaphylaxis are extremely rare and are not related to the speed at which iron polymaltose is given. - Oral iron tablets are not effective in many patients for a number of reasons. It would labour intensive, expensive and inconvenient to bring all these patients back to a ward for a 1-2 hour infusion of iron polymaltose after surgery. Other intravenous iron preparations, with similar pharmacological properties, have been shown to be safe when given over similar short periods of time and we believe this will be the case with iron polymaltose too. Some anaesthetists (in Australia and NZ) have already administered iron polymaltose in this manner with no anecdotal reports of any problems, however we believe it warrants formal evaluation. Study Design and Methods We aim to recruit 100 patients with iron deficiency anaemia or iron deficiency who are scheduled to undergo general anaesthesia for an elective surgical procedure. Routine care will be unaffected and they will receive general anaesthesia as they would if they were not involved in this trial. Following commencement of surgery and during a period of haemodynamic stability (as assessed by the responsible anaesthetist), they will receive an iron polymaltose infusion over a 10 min period and we will collect data on any adverse effects and change in blood pressure over this time. In order to assess the haemodynamic impact of the infusion, any changes in blood pressure will be compared to the decrease in blood pressure seen at the start of the anaesthetic. Outcomes Primary outcome will be the incidence of significant low blood pressure following the administration of iron polymaltose (definition = systolic BP less than 80mmHg or blood pressure treatment required). Secondary outcomes, will be the incidence of all adverse effects as ascertained by questionnaire 2 hours after surgery and changes in blood markers of iron deficiency. Potential Benefits / Ethical Issues The current drug manufacturers product information sheet, recommends a slow infusion of iron polymaltose over approximately 4.5 hours, however most WA hospitals already administer iron polymaltose over a shorter periods of time, with no serious problems. We believe that if we demonstrate this technique of administration is safe it may lead to more effective & widespread treatment of iron deficiency and anaemia in surgical patients

At Genea frozen embryo transfer pregnancy success rates have improved to a level close to fresh embryo transfer success rates. The embryos used in the frozen cycles are the second and third best embryos - as graded for development rate and morphology- compared to the embryos transferred in the fresh cycles when the best quality embryo is selected for transfer to the uterus. The hormone stimulation undertaken prior to oocyte collection may affect the endometrium (uterine lining) - advancing it to a stage whereby the embryo implantation prospect could be impaired and therefore reducing the chance of an ongoing pregnancy. The hypothesis is that freezing of all embryos may help to overcome any reduction in implantation potential by allowing improved synchronisation between the embryo and the endometrium, leading to both higher implantation and pregnancy rates. There are a number of causes of pregnancy failure following IVF treatment including genetically abnormal embryos, poor quality embryos and potentially a non-receptive uterine environment. The transfer of genetically and morphologically normal embryos into a non-receptive uterine environment will likely not achieve a pregnancy. Generally the suitability of the uterine environment is measured by ultrasound. However such measurement is not able to provide full information on how the uterus has developed under the influence of hormone stimulation drugs used routinely in an IVF treatment cycle. Genea has extensive experience with vitrification technology having been the first clinic to introduce the procedure into routine clinical practise in Australia, January 2006. Subsequently the technology has been performed routinely in all Genea laboratories following IVF, ICSI and PGD treatment cycles. More than 1000 babies have now been born after vitrification at Genea. The vitrification procedure used in this study will be applied to embryos cultured at the Genea Kent Street laboratory for 5 days (blastocyst stage). By vitrifying and NOT TRANSFERRING embryos in “routine” IVF cycle fresh, we wish to see if this will: increase the chance of fetal heart pregnancy and increase the chance of a live born baby

This project is part of a research program funded by the NHMRC (No. 630560) to develop and evaluate Internet based transdiagnostic education and treatment programs for people with anxiety and depression. This project examines the relative efficacy of a disorder-specific internet-delivered treatment for depression vs. trans-diagnostic internet-delivered treatment for both anxiety and depression. Both interventions will be tested in guided and self-guided formats. We expect that the guided interventions will results in superior outcomes to the unguided interventions. We do not expect differences between the two guided interventions at post-treatment, but expect that the trans-diagnostic treatment will result in superior outcomes at follow-ups.

The aim of this trial is to examine whether D-Cycloserine can augment a single session of graded exposure therapy in children and adolescents with a specific phobia. D-Cycloserine is an antibiotic drug traditionally used to treat tuberculosis. D-Cycloserine is a glutamatergic partial N-methyl-D-aspartate (NDMA) agonist, which has recently been shown to facilitate fear extinction in humans and animals and has also demonstrated to improve treatment outcome when combined with exposure therapy in social phobia, acrophobia or fear of heights and OCD in adult samples. The drug has recently been successfully used to augment exposure therapy for children and adolescents with OCD.

Despite the use of high dose chemotherapy and ASCT (a procedure where the patient's own cells are collected, high dose therapy eliminates patient's cancer cells and patient's collected cells are reinfused), multiple myeloma remains incurable. This study aims to: 1.compare induction therapy employing either a chemotherapy regimen employing Bortezomib, melphalan and prednisolone or high dose therapy and ASCT 2. compare consolidation therapy employing either a chemotherapy regimen of bortezomib, lenalidomide and dexamethasone or no treatment 3. investigate maintenance therapy employing lenalidomide The study plans to treat 1500 patients worldwide. Trial details In this study you will receive the drug bortezomib delivered intravenously (i.v) on days 1,4,8 and 11, the drug cyclophosphamide delivered i.v on days 1 and 8, and dexamethasone delivered orally on days 1,2,4,5,8,9,11 and 12 of a 21 day treatment cycle you will then be allocated to receive either option in 1. and either option in 2. below 1. either 4 cycles of the drug bortezomib delivered intravenously (i.v) on days 1,4,8, 11, 22, 25, 29 and 32, the drug melphalan delivered orally on days 1 -4 and prednisolone delivered orally on days 1-4 of a 6 week cycle;or high dose melphalan i.v 3 and 2 days before reinfusion of patient's own stem cells 2. either 2 cycles of consolidation treatment consisting of the drug bortezomib delivered intravenously (i.v) on days 1,4,8 and 11, the drug lenalidomide delivered orally on days 1-21, and dexamethasone delivered orally on days 1,2,4,5,8,9,11 and 12 of a 28 day treatment cycle or no consolidation treatment All patients will then receive repeating 28 day cycles of daily oral lenalidomide therapy as long as the therapy continues to fight the myeloma. Your response to the treatment will be assessed at routine clinical visits using the usual clinical investigations that would monitor the status of your disease. Who is it for? This study is open to male or female patients aged 18-65 with a diagnosis of multiple myeloma. The full details of this study's inclusion and exclusion criteria can be found in the relevant sections within this record.

This study will test the primary hypothesis that nebulised heparin ameliorates the severity of lung damage resulting in faster recovery of physical function in critically ill patients with, or at risk of developing, ARDS. Other aims of the study include determining if nebulised heparin improves quality of life, shortens intensive care and hospital lengths of stay and is cost-effective.

This study is to see whether taking the drug metformin in addition to drug aromatase inhibitor can stop cancer cell activity in hormone receptor positive breast cancer in post menopausal women waiting for surgery. Who is it for? This study is open to postmenopausal women aged 18 and over, with Stage 1 or 2 operable invasive breast cancer scheduled for surgery. Further inclusion and exclusion details for this study can be found in the relevant sections in this form. Trial details In this study, you will be randomised to one of two groups. Arm 1 will involve taking 2 weeks of metformin (oral tablets, 1 gm per day) followed by 2 weeks of metformin (oral tablets, 1gm per day) in addition to aromatase inhibitor (oral tablets 1 mg per day Arimidex (trade name) or oral tablets 2.5 mg per day Femara (trade name)) in the lead up to your scheduled surgery. If you are randomised to Arm 2, you will receive 2 weeks of metformin (oral tablets, 1gm per day) followed by 2 weeks of aromatase inhibitor alone (oral tablets 1 mg per day Arimidex (trade name) or oral tablets 2.5 mg per day Femara (trade name).

Demographic trends resulting in increased longevity and an increasingly aged population, combined with the current economic climate, indicate that there will be rising demand placed on already stretched health resources. This is accentuated by the rural location of the Mackay Health Service District (MHSD) which leads to a disproportionate amount of patient and clinician time being spent on travel, as compared to metropolitan services. Within Mackay Base Hospital there are pressures on bed availability (average 96.5% bed occupancy), necessitating innovative early discharge / admission prevention strategies. In addition, patients may be admitted unnecessarily because; they are nearing their emergency department (ED) wait limit target; there are limited and variable Allied Health (AH) services available for ED referrals; or existing ED staff do not have a detailed awareness of community services available to address these patients’ rehabilitation needs. Compounding this, anecdote suggests that there are inefficiencies within existing AH service delivery models; that tasks are duplicated by health professionals, that patients are frustrated by repeating information to AH staff involved in their care, that Allied Health Assistants (AHAs) are under utilised and that services are often fragmented. Increasing pressures on services, staff shortages and lone working, common in regional areas, has led to clinicians informally skill sharing, albeit in an ad-hoc and unstructured fashion, often without the requisite training and competence to enable them to be effective, or to recognise when they are out of their depth. There is inherent risk in this practice, unless a rigorous process has been followed to identify and risk analyse tasks for their appropriateness to share across professional boundaries or delegate. There is subjective information indicating that many tasks are undertaken by qualified practitioners that could be delegated to AHAs, and that there are tasks that can’t be delegated but don’t require highly specialist knowledge and skills to perform, for example routine assessments / interventions. In these instances, it is intuitively sensible to identify which tasks could be delegated / shared across professional boundaries, to use the skill set of the multi-disciplinary team (MDT) more effectively. The Calderdale Competency Framework is a systematic approach to identifying tasks carried out in teams, deciding which can be shared across professional boundaries, or delegated, and assessing competence. Following implementation of the Calderdale Framework, AH practitioners share professional skills across AH disciplines and increase delegation of tasks to AHAs, reducing the number of professionals involved in a patient’s care and minimising duplication of interviews, assessments, interventions, documentation and travel. The Calderdale Competency Framework has numerous potential benefits for the patients, clinicians and organisations, including: Patients are able to form a rapport with 1 individual who can meet most needs, reducing the number of visitors to their home or bedside - more rounded, holistic knowledge of the patient Access to a wider range if interventions for patients living in rural / remote areas Reduced repetition of personal details, condition history and assessments - reduced travel costs and duplication of tasks / roles Closer MDT working - Multi skilled staff - effective team built around the patient Increased awareness and respect of one another’s roles - more issues are identified and addressed - awareness of when staff need to seek the involvement of their colleagues Each discipline’s areas of expertise are identified - guides focus of resources Safe skill sharing / transferable skills Multi skilled workforce using the full scope of practice and delegating appropriately Increased job satisfaction – clarified roles and responsibilities - reduction in staff absence Less ‘hand offs’ - No need for patient handover Improved service productivity / patient flow Management of increased demands Although this framework has been applied in many settings in the UK, it has not been used previously in Australia and the clinical effectiveness of this model of care (MoC) has never been evaluated. In Queensland Health, this model of care is known as shared competencies and delegation practice (SCDP). The proposed study aims to examine the clinical and cost effectiveness in SCDP in relation to its current implementation in the Mackay Health Service District. All AH tasks carried out within the Emergency Department (ED) in the Mackay Health Services District will be identified and, using a risk management decision tool, tasks will be categorised into those that should be delegated to support staff, those that could be professionally skill shared and those which should remain uni-disciplinary. Competencies will be written / sourced and multi-disciplinary team (MDT) staff will teach each other skills, which have historically been considered their role. An Occupational Therapist and a Physiotherapist will then operate Shared Competencies and Delegation Practice within the ED setting. MDT staff will be fully engaged at all stages of the process to ensure sign up. The model is likely to enable patients, triaged to ED categories 2/3/4 (n=27,156 July 2010 - February 2011), to be assessed by AH staff quickly and admission avoided or length of stay reduced, as MDT assessments would have already been completed and discharge planning initiated. The nursing and medical input to patients will not be affected by this study. Aim(s) of project/study This study aims to determine the clinical and cost effectiveness in implementing a SCDP MoC with older people presenting to the ED. Research questions Is Shared Competencies and Delegation Practice (SCDP) clinically effective in enhancing patients’ functional independence, in an Emergency Department (ED) setting, as compared to usual care? Is SCPD cost effective? A prospective Randomised Controlled Trial design will be used with blinding of participants, outcome assessors and statistical analysts. Data will be collected at baseline, on discharge from Allied Health intervention and at 4 months post randomisation. The Cost Utility Study will be carried out from a societal perspective with both direct and indirect costs identified. The primary measure of benefit will be quality of life as measured by the Euroqol. Clients who attend the ED between the hours of 8am – 6pm Monday to Saturday, meet the study inclusion criteria and provide written informed consent to participate will be randomised to the intervention or control groups. The intervention group will receive AH input from clinicians trained in Shared Competencies and Delegation Practice whilst in ED, with follow-up on the ward or in the community if required. The AH clinicians based in the ED will be an occupational therapists and physiotherapists, by clinical background, but will be additionally trained in occupational therapy / physiotherapy / speech pathology / dietetics / podiatry and social work competencies. Thus, clinicians will be able to complete a more a rounded assessment and target intervention to meet the client’s complex needs. Intervention will aim to maximise functional independence, prevent admission and minimise the number of AH clinicians involved in a client’s care. An intervention protocol will be developed to ensure consistency in this approach. The control group will receive standard care, which comprises of clients being referred to individual disciplines, as the need is identified by the Community: Hospital Interface Programme (CHIP) nurses in the ED. Individual disciplines will then intervene with the clients using existing uni-disciplinary approaches and refer on to other services as indicated. Standard care will be documented via an audit prior to trial commencement to ensure that it can be clearly defined at the outset.